Valeo Spacer System - VALEO Z 99x99mm x 99mm height 6º Lordosis, - AMEDICA CORPORATION

Duns Number:028629553

Device Description: VALEO Z 99x99mm x 99mm height 6º Lordosis, textured

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More Product Details

Catalog Number

11.009.1605

Brand Name

Valeo Spacer System

Version/Model Number

C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

294072cc-aa93-456e-bbff-49147ea18376

Public Version Date

February 24, 2020

Public Version Number

5

DI Record Publish Date

September 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMEDICA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 3000